Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b)
Summary
The FDA issued a Class I for Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Ta by Amneal Pharmaceuticals, LLC. Reason: Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination..
Details
Source
Drug Recall
External ID
D-0488-2025
Action Date
2025-06-18
Status
Ongoing
Category
drug
Product Description
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
Lot/Code Info: Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
Quantity Affected: 6396 bottles
Reason for Recall
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-02
Company
Bridgewater, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 54 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Amneal Pharmaceuticals, LLC has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Amneal Pharmaceuticals, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Amneal Pharmaceuticals, LLC have FDA actions?
Amneal Pharmaceuticals, LLC has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0488-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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